Phase 2
Completed N=51
A Study of E7080 in Subjects With Advanced Thyroid Cancer
Source: ClinicalTrials.gov NCT01728623 ↗Enrolled (actual)
51
Serious AEs
52.9%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 100.0; 82.4; 52.9; 2.0 Percentage of participants
Summary
This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
100.0; 82.4; 52.9; 2.0; 96.1; 66.7 | — |
| SECONDARY Progression-free Survival (PFS) |
25.8; 9.2; 7.4 | — |
| SECONDARY Overall Survival (OS) |
31.8; 12.1; 10.6 | — |
| SECONDARY Best Overall Response (BOR) |
0; 0; 0; 68.0; 22.2; 23.5 | — |
| SECONDARY Objective Response Rate (ORR) |
68.0; 22.2; 23.5 | — |
| SECONDARY Disease Control Rate (DCR) |
100.0; 100.0; 94.1 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
84.0; 77.8; 70.6 | — |
Eligibility Criteria
Inclusion criteria
- Histologically or clinically diagnosed with thyroid cancer
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
- Adequate laboratory values/organ function tests
Exclusion criteria
Participants with following complication or disease history
- Brain metastasis
- Systemic severe infection
- Significant cardiovascular impairment
- QTc greater than 480 milliseconds
- Active hemoptysis
- Bleeding or thrombotic disorders
- Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria
- Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080
- Major surgery within 3 weeks before enrollment
- With co-existing effusion requiring drainage
Data sourced from ClinicalTrials.gov (NCT01728623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.